1. Technical Field
The present disclosure relates an apparatus and methods for anastomosing two hollow body parts and, more particularly to apparatus and methods for anastomosing a urethral stump of a patient to the bladder following a radical prostatectomy.
2. Background of Related Art
Most body conduits are generally cylindrical in configuration and have a circular cross-section. When it is desired to suture such a conduit, typically for attachment to another body conduit, sutures are placed around the circumference of the conduit in order to maintain the patency of its lumen or channel. This type of attachment is commonly referred to as an anastomosis. It can be appreciated that the sutures made on top of the conduit (i.e., on the side facing the surgeon) in an anastomosis are made relatively more easily than the sutures made underneath the conduit (i.e., on the side facing away from the surgeon).
The complexity of anastomosis attachment is made manifestly apparent in a surgical procedure referred to generally as a radical prostatectomy (i.e., a well established surgical procedure for patients with localized prostatic carcinoma). In general, radical prostatectomy procedures require the removal of cancerous tissue while preserving sexual function and continence in the patient. There are two primary types of radical prostatectomy approaches for the removal of prostate cancer, the retropubic approach and the perineal approach.
In the retropubic approach, a long up-and-down incision is made in the midline of the abdomen from the navel to the pubic bone. After the lymph nodes have been removed for study by the pathologist and a determination has been made to proceed with the removal of the prostate gland, the space underneath the pubic bone is cleaned and dissected and the removal of the entire prostate gland is generally begun at the end that is farthest from the bladder, i.e., next to the external urethral sphincter. Next, the prostatic urethra is divided, the prostatic urethra and the prostate gland through which it goes are then pulled upwards toward the bladder while the dissection continues behind the prostate gland, separating it from the layer of tissue that is connected to the rectum on its other side. As the dissection continues between the prostate and the rectum, the seminal vesicles, which are behind the base of the bladder will be removed along with the prostate gland. Once the seminal vesicles are free, the entire prostate gland and the seminal vesicles are removed. The bladder neck is then stitched closed to a small enough diameter so that it is about the same size as the stump of the urethra from which the prostate was detached. The bladder neck is then pulled down into the pelvis and positioned against the urethral stump and stitched thereto. This stitching is done typically around a Foley catheter which has been inserted through the penis all the way into the bladder.
In the perineal approach, an inverted “U” shaped incision is made going right over the anus, with the center of the “U” about three centimeters above the margin of the anus. The prostate gland is then freed from its surrounding structures by gentle dissection, and the urethra at the end of the prostate farthest from the bladder is isolated and divided. The bladder neck is freed from the prostate, and, once the prostate gland has been removed and the bladder neck has been closed sufficiently so that the size of its opening approximates the size of the urethral opening, the urethra and the bladder neck are stitched together. Once again, a Foley catheter is left in place postoperatively for about two weeks.
In each of the above described procedures, it is the attachment of the urethral stump to the bladder neck which is particularly difficult and complex. This difficulty is complicated by the tendency of the urethral stump to retract into adjacent tissue. As a result, considerable time and effort must be expended to re-expose the urethral stump and begin the re-anastomosis procedure. Further complicating this procedure is the fact that the urethral stump is hidden beneath the pubic bone thus requiring that the surgeon work at a difficult angle and in positions that are uncomfortable and limiting.
Various devices have been proposed for facilitating this procedure. In U.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed a suturing device including a shaft with portions defining an interior channel extending between a proximal and a distal end of the shaft. This channel includes a generally axial lumen which extends to the proximal end of the shaft and a generally transverse lumen which extends from the axial lumen distally outwardly to an exit hole at the outer surface of the shaft. A needle and suture can be back loaded into the transverse lumen of the channel while a generally non-compressible member can be movably mounted in the axial lumen of the channel. At the proximal end of the shaft a handle is provided with means operative to push the member distally through the lumen to deploy or expel the needle.
In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a suture guide with a curved distal portion. The distal portion of the suture guide has a plurality of exterior axial grooves which can be used to align and guide a curved needle and attached suture. In order to drive the urethral stump to an accessible position, the device is provided with a plurality of outwardly extendable members which engage the lumen of the urethra. These members make it possible to push the urethral stump into approximation with the bladder neck.
In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed a surgical device for the ligation of a dorsal vein and subsequent anastomosis. This device contains a pair of enclosed needles each having an attached suture which needles may be driven from the shaft of the device into adjacent tissue.
In general, none of the devices disclosed in the prior art references above is simple to use or makes the anastomosis of the urethral stump to the bladder neck easier. As such, each surgical procedure using the prior art devices continues to be time consuming and to require great skill. In addition, these prior art references do not disclose a suture device which can accurately position a plurality of anchor and suture combinations, for use at or near the severed end of a body conduit, simultaneously. Accordingly, the need exists for radical prostatectomy anastomosis devices which overcome the drawbacks of the prior art devices and which are quick and simple to use.
Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. Apparatus according to the present disclosure include a sleeve having a proximal and a distal end and defining a longitudinal axis and a tubular body configured and adapted to be slidably received within the sleeve, the tubular body defining a central lumen extending longitudinally therethrough.
The apparatus further include a firing head operatively coupled to a distal end of the tubular body. The firing head has a recess co-axially aligned and interconnected with the central lumen of the tubular body. The firing head further includes at least one needle passage formed therein and extending into the central lumen of the tubular body.
The apparatus include an anchor configured and adapted to be received within the distal end of the sleeve. The anchor has a hub, a plurality of resilient arms extending from the hub and an annular flange extending from a proximal surface of the hub. Each of the plurality of arms has a first position in axial alignment with the longitudinal axis of the sleeve and a second position orthogonal to the longitudinal axis of the sleeve. The anchor further includes a central passage extending through the hub and the annular flange.
The apparatus further include a needle pusher assembly having at least one push rod slidably received within a respective needle passage. A lock collar is provided which is configured and adapted to be tightly fit in the central passage of the anchor. The lock collar is held within the recess of the firing head by at least one break-away tab extending from an outer surface of the lock collar to an inner surface of the recess of the fining head.
The apparatus include at least one needle anchor having a suture secured thereto. The at least one needle anchor is slidably received in a respective needle passage. The suture runs from the at least one needle anchor, out a respective needle passage, into the central passage of the anchor through a respective hole formed in the flange, proximally into the recess of the firing head, between the lock collar and the firing head and proximally through the central lumen of the tubular body.
A preferred method of performing a surgical anastomotic procedure, using apparatus disclosed herein, includes providing apparatus as disclosed above, removing the prostate gland, freeing the urethra from the prostate gland to thereby define a urethral stump, freeing the prostate gland from the bladder to define a bladder neck, loading the distal end of the sleeve with the anchor such that each of the plurality of arms of the anchor are in the first position, passing the apparatus trans-urethrally through the urethra until the anchor is positioned entirely within the bladder, deploying the anchor by withdrawing the sleeve proximally so that the arms are in the second position, withdrawing the sleeve and tubular body proximally through the urethra until the needle passages are within the urethra, firing the needle anchors through the urethra by driving the push rods of the pusher assembly distally through the central lumen of the tubular body, approximating the bladder to the urethra by pulling on the at least one suture, holding the at least one suture in place, advancing the tubular body through the urethra and fitting the lock collar into the flange of the anchor to thereby fix the at least one suture in place, withdrawing the apparatus and cutting the at least one suture.
The presently disclosed anastomosis apparatus, together with attendant advantages, will be best understood by reference to the following detailed description in conjunction with the figures below.